BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6979753 · Received October 26, 2017

    Report

    Report Number
    3005099803-2017-03142
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 3, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    PCU
    UDI-DI
    08714729904595
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED AUGUST 1, 2018. BLOCKS PATIENT IDENTIFIER, ADVERSE EVENT OR PRODUCT PROBLEM, OUTCOMES ATTRIBUTED TO ADVERSE EVENT, DATE OF EVENT UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS IMPLANTED TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE IMPLANTATION SITE WAS EXAMINED WITH EUS DOPPLER PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, NINE DAYS AFTER THE STENT WAS PLACED, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE STENT AS THE PSEUDOCYST HAD COLLAPSED. DURING THIS PROCEDURE, THE PATIENT EXPERIENCED SEVERE BLEEDING DUE TO EROSION INTO THE SPLENIC ARTERY. THE PATIENT'S BLEEDING WAS PROFOUND WITH SHOCK AND SYNCOPE. THE PATIENT RECEIVED A 5 UNIT TRANSFUSION AND UNDERWENT A RESCUE ANGIOGRAPHIC EMBOLIZATION OF THE SPLENIC ARTERY. THE AXIOS STENT WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A PIGTAIL STENT. THE PATIENT WAS REPORTED TO BE RECOVERING. ADDITIONAL INFORMATION RECEIVED AUGUST 1, 2018. IN (B)(6) 2017, THE PATIENT EXPERIENCED PAIN AND RECEIVED A CT SCAN, WHICH SHOWED A 8.9CM PANCREATIC PSEUDOCYST. ON (B)(6) 2017, THE PATIENT COLLAPSED AND WAS VOMITING BLOOD AND BLEEDING FROM THE RECTUM. ACCORDING TO THE PATIENT¿S ACCOUNT, THE PATIENT LOST 7 PINTS OF BLOOD AND WAS IN THE ICU. A CT SCAN SHOWED WIRES STICKING OUT ALL OVER THE STENT AND A LACERATION OF THE PATIENT'S SPLEEN. REPORTEDLY, THE PATIENT¿S PANCREAS IS HELD TOGETHER WITH 3 PIGTAIL STENTS. THE PATIENT HAS BECOME DIABETIC.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS IMPLANTED TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE IMPLANTATION SITE WAS EXAMINED WITH EUS DOPPLER PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, NINE DAYS AFTER THE STENT WAS PLACED, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE STENT AS THE PSEUDOCYST HAD COLLAPSED. DURING THIS PROCEDURE, THE PATIENT EXPERIENCED SEVERE BLEEDING DUE TO EROSION INTO THE SPLENIC ARTERY. THE PATIENT'S BLEEDING WAS PROFOUND WITH SHOCK AND SYNCOPE. THE PATIENT RECEIVED A 5 UNIT TRANSFUSION AND UNDERWENT A RESCUE ANGIOGRAPHIC EMBOLIZATION OF THE SPLENIC ARTERY. THE AXIOS STENT WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A PIGTAIL STENT. THE PATIENT WAS REPORTED TO BE RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760403 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00553650 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention